Efficacy and tolerability of sumatriptan injection for the treatment of morning migraine: Two multicenter, prospective, randomized, double-blind, controlled studies in adults

Clinical Therapeutics

Volumn 28, Issue 10, 2006, Pages 1582-1591

  Winner, Paul ^a   Adelman, James ^b   Aurora, Sheena ^c   Lener, Michelle E ^d   Ames, Michael ^d  

^a Palm Beach Headache Center   (United States)

^b Headache Wellness Center   (United States)

^c Swedish Headache Center   (United States)

^d GLAXOSMITHKLINE   (United States)

Author keywords

injectable therapy; migraine; morning; sumatriptan

Indexed keywords

PLACEBO; SUMATRIPTAN SUCCINATE;

ADULT; AGED; ANALGESIA; ARTICLE; CLINICAL FEATURE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOSE TIME EFFECT RELATION; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG TOLERABILITY; EVALUATION AND FOLLOW UP; FEMALE; HUMAN; INJECTION SITE BURNING; INJECTION SITE REACTION; INJECTION SITE STINGING; MAJOR CLINICAL STUDY; MALE; MIGRAINE; MULTICENTER STUDY; NAUSEA; OUTPATIENT CARE; PHYSICIAN; RANDOMIZED CONTROLLED TRIAL; SINGLE DRUG DOSE; STATISTICAL SIGNIFICANCE; TREATMENT OUTCOME;

ADULT; DOUBLE-BLIND METHOD; FEMALE; HUMANS; MALE; PLACEBOS; SEROTONIN AGONISTS; SUMATRIPTAN;

EID: 33751506074     PISSN: 01492918     EISSN: 1879114X     Source Type: Journal    
DOI: 10.1016/j.clinthera.2006.10.011     Document Type: Article

References (18)

1. Available at:. Matchar D.B., Young W.B., Rosenberg J.H., et al. Evidence based guidelines for migraine headache in the primary care setting: Pharmacological management of acute attacks. US Headache Consortium Guidelines. Accessed (April 3, 2002). http://www.aan.com/public/practiceguidelines/03.pdf
2. Hu X.H., Raskin N.H., Cowan R., et al., United States Migraine Study Protocol (USMAP) Group. Treatment of migraine with rizatriptan: When to take the medication. Headache 42 (2002) 16-20
3. Cady R.K., Sheftell F., Lipton R.B., et al. Effect of early intervention with sumatriptan on migraine pain: Retrospective analyses of data from three clinical trials. Clin Ther 22 (2000) 1035-1048
4. Subcutaneous Sumatriptan International Study Group. Treatment of migraine attacks with sumatriptan. N Engl J Med 325 (1991) 316-321
5. Cady R.K., Wendt J.K., Kirchner J.F., et al. Treatment of acute migraine with subcutaneous sumatriptan. JAMA 265 (1991) 2831-2835
6. Ferrari M.D., Roon K.I., Lipton R.B., and Goadsby P.J. Oral triptans (serotonin 5-HT(1B/1 D) agonists) in acute migraine treatment: A meta-analysis of 53 trials. Lancet 358 (2001) 1668-1675
7. Fox A.W., and Davis R.L. Migraine chronobiology. Headache 38 (1998) 436-441
8. Bousser M.G., D'Allens H., Richard A., and Early-Morning Migraine Sumatriptan Study Group. Efficacy of subcutaneous sumatriptan in the acute treatment of earlymorning migraine: A placebo-controlled trial. J Intern Need 234 (1993) 211-216
9. Available at:. European Agency for the Evaluation of Medicinal Products. Accessed June 15, 2005. International Conference on Harmonisation-World Health Organization. Guideline for Good Clinical Practice [EMEA Web site]. ICH Topic E6 (2002), WHO, Geneva, Switzerland. http://www.emea.eu.int
10. Available at:. World Medical Association Declaration of Helsinki. Recommendations Guiding Medical Doctors in Biomedical Research Involving Human Subjects [WMA Web site]. Accessed June 15, 2005 (1989), WMA, Ferney-Voltaire, France. http://www.wma.net
11. Headache Classification Committee of the International Headache Society. Classification and diagnostic criteria for headache disorders, cranial neuralgias and facial pain. Cephalalgia 8 Suppl 7 (1988) 1-96
12. Available at:. Headache ImpactTest 6 (HIT 6). Accessed June 15, 2006 (2006), Quality Metric, Inc, Lincoln, RI. http://www.headachetest.com/
13. Ware J., Kosinski M., Dahlof C., et al. Validity of HIT 6, a paper-based short form for measuring headache impact. Cephalalgia 21 (2001) 333
14. Ware Jr. J.E., Bjomer J.B., and Kosinski M. Practical implications of item response theory and computerized adaptive testing: A brief summary of ongoing studies of widely used headache impact scales. Med Care 38 Suppl 9 (2000) 1173-1182
15. Garber W.H., Kosinski M., Dahlof C., et al. HIT-6 reliably measures the impact of headache. Cephalalgia 21 (2001) 333
16. Dowson A., Dahlof C., Malik F., and Pham B. A multicentre study investigating the association between disability (using Headache Impact Test HIT 6) and I HS classification (as determined by an expert panel diary review). Cephalalgia 22 (2002) 28
17. Mushet G.R., Cady R.K., Baker C.C., et al. Efficacy and tolerability of subcutaneous sumatriptan administered using the IMITREX STATdose System. Clin Ther 18 (1996) 687-699
18. Gross M.L., Kay J., Turner A.M., et al., United Kingdom Study Group. Sumatriptan in acute migraine using a novel cartridge system self-injector. Headache 34 (1994) 559-563